Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

在进入 iENGAGE 时整合参与和遵守目标以控制 HIV

• 批准号: 8495270
• 负责人: MICHAEL J MUGAVERO
• 金额: $ 70.23万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-21 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8495270
• 关键词: AIDS prevention; Address; Adherence; Area Under Curve; Behavior; Behavioral; Biostatistics Core; Caring; Centers for Disease Control and Prevention (U.S.); Climacteric; Clinic; Clinic Visits; Clinical; Collaborations; Communities; Complex; Counseling; Data; Development; Diagnosis; Disclosure; Education; Epidemiology; Event; Evidence based intervention; Face; Failure; Fostering; Foundations; Goals; Growth; HIV; HIV Infections; HIV diagnosis; Health; Health Benefit; Health Care Visit; Human immunodeficiency virus test; Individual; Intervention; Intervention Studies; Life; Life Experience; Link; Measurement; Mediator of activation protein; Medical; Modeling; Monitor; Motivation; Outcome; Outcome Measure; Outpatients; Patients; Persons; Pharmaceutical Preparations; Plasma; Play; Prevention; Professional counselor; Qualifying; Relative (related person); Research Infrastructure; Research Personnel; Resources; Role; Science; Self Care; Structural Models; Subgroup; System; Testing; Time; Training; United States National Institutes of Health; Viral Load result; Viremia; Visit; Work; antiretroviral therapy; base; clinical care; cohort; data management; empowered; evidence base; experience; innovation; instrument; meetings; novel; population health; skills; standard of care; theories; therapy adherence

DESCRIPTION (provided by applicant): The first year of outpatient HIV medical care is a dynamic, formative and vulnerable time. While adjusting to a life changing diagnosis, patients must simultaneously develop HIV visit adherence and antiretroviral therapy (ART) adherence behavioral skills to achieve plasma viral load (VL) suppression. Moreover, maintaining "HIV adherence" in a broader context is essential to sustaining VL suppression over time, with vital consequences to individual health and profound implications for secondary HIV prevention. It is alarming that no existing evidence-based intervention supports the simultaneous development of patient information, motivation and behavioral skills for both HIV medical visit and ART adherence at this critical time. Accordingly, we will draw content from our existing, pilot-tested interventions that target these separate adherence behaviors to evaluate an integrated intervention approach tailored to the needs of an individual initiating outpatient HIV medical care. The proposed iENGAGE intervention (integrating ENGagement and Adherence Goals upon Entry) has two overarching goals: (1) to facilitate patient adjustment to a new diagnosis of HIV infection, and, (2) to develop the necessary patient information, motivation and skills for optimal HIV visit and ART adherence. The following specific aims are driven by a unified conceptual model, linked with explicit measurement instruments, and a detailed analysis plan. Aim 1: Integrate content from our pilot-tested and evidence-based CDC Retention in Care and PACT ART adherence interventions for the comprehensive iENGAGE intervention to promote VL suppression (<50 c/mL) among patients newly initiating outpatient HIV medical care. Aim 2: Evaluate the efficacy of the iENGAGE intervention vs. standard of care in achieving 48-week VL suppression (<50 c/mL) among patients newly initiating outpatient HIV medical care. Aim 3: Evaluate (a) modifiers and (b) mediators of iENGAGE efficacy, using (a) subgroup analysis to estimate important subgroup effects and (b) marginal structural models to estimate the role of intervention components in the overall effect. Identify (c) baseline and longitudinal predictors of VL outcomes using marginal structural models among patients receiving standard of care. Our investigative team has a strong track record of collaboration and the collective expertise in HIV behavioral, clinical, and epidemiological sciences to successfully complete this innovative scope of work. Considerable emphasis and resources have appropriately focused on expanding HIV testing, and interventions have proven efficacious in linking patients from the community to an HIV clinic. In contrast, a paucity of intervention research has focused on patients newly initiatin outpatient HIV medical care. The iENGAGE intervention aims to convert this vulnerable time to a teachable moment during which patients develop information, motivation and adherence skills to achieve and sustain VL suppression. Study findings will play a pivotal role in addressing the scientific void around this dynamic period - a critical time if we are to maximally realize the individual and population health benefits (i.e., treatment as prevention) of VL suppression.

描述（由申请人提供）：门诊艾滋病毒医疗护理的第一年是动态，形成和脆弱的时间。在适应改变生活诊断的同时，患者必须同时发展HIV就诊依从性和抗逆转录病毒疗法（ART）依从性行为技巧，以实现血浆病毒载量（VL）抑制。此外，在更广泛的背景下保持“艾滋病毒依从性”对于随着时间的推移维持VL抑制至关重要，这对个人健康和对次要艾滋病毒的预防产生了重要影响。令人震惊的是，在这个关键时刻，没有现有的基于证据的干预支持HIV医学访问和艺术依从性的患者信息，动机和行为技能的同时发展。因此，我们将从现有的，试验性测试的干预措施中汲取内容，这些干预措施针对这些单独的依从性行为，以评估根据启动门诊HIV医疗服务的个人需求量身定制的综合干预方法。拟议的IENGAGE干预（进入进入后的互动和依从性目标）具有两个总体目标：（1）促进患者调整艾滋病毒感染的新诊断，以及（2）开发必要的患者信息，动机和技能，以进行最佳的艾滋病毒访问和艺术。以下特定目标是由统一的概念模型驱动的，与明确的测量工具和详细的分析计划相关联。 AIM 1：将我们的试验性测试和基于证据的CDC保留的内容整合到CART和PACT ART依从性干预措施中，以全面的IENGAGE干预措施，以促进新启动门诊HIV医疗服务的患者中VL抑制（<50 c/mL）。 AIM 2：评估IENGAGE干预与护理标准在实现48周VL抑制（<50 c/ml）的疗效中，在新启动门诊HIV医疗的患者中。目标3：评估（a）修饰符和（b）IENGAGE功效的介导子，使用（a）亚组分析估算重要的亚组效应和（b）边缘结构模型，以估计干预成分在整体效应中的作用。确定（c）基线和纵向预测指标 在接受护理标准的患者中使用边际结构模型的VL结果。我们的调查团队拥有合作的良好记录以及艾滋病毒行为，临床和流行病学科学方面的集体专业知识，以成功完成这一创新的工作范围。相当大的重点和资源已适当地集中在扩大艾滋病毒测试上，而干预措施已被证明有效地将社区患者与艾滋病毒诊所联系起来。相比之下，干预研究的匮乏集中在新肠门诊门诊HIV医疗护理上。 IENGAGE干预旨在将这个脆弱的时间转变为一个可教的时刻，在此期间，患者发展了信息，动机和依从性，以实现和维持VL抑制。研究结果将在解决这个动态时期的科学空隙方面发挥关键作用 - 如果我们要最大程度地意识到对VL抑制的个人和人口健康益处（即预防治疗），那么这是关键的时间。